Submit offer Competence Development Program for Medtech Startups in Beyond Beta

The Beyond Beta program supports the Danish startup ecosystem from the initial idea to investment and scaling by providing founders with the right network, knowledge, and navigation tools.
Danish Life Science Cluster acts as a mentor organization for start-ups within life science and welfare technology.

As part of the Beyond Beta program, we are inviting proposals for Competence Development Program for Medtech and Life Sciences Startups. 

GENERAL INFORMATION
Title of tender: Competence Development Program for Medtech Startups in Beyond Beta
Your company’s name: Danish Life Science Cluster
Address: Lersø Parkallé 101, 2100 København Ø
CVR nr.: 41894946
Date: 20/10-2025
Deadline for tender: 29/10-2025
For further questions, contact info: Project Manager Charlotte Søgaard Kristensen, csk@danishlifesciencecluster.dk
 
2. BRIEF PRESENTATION OF THE BEYOND BETA PROGRAM
Danish Life Science Cluster is dedicated to supporting early-stage medtech startups by combining practical experience in medtech device development with deep insights into regulatory and production requirements. Our mission is to strengthen the competencies of participating startups, enabling them to accelerate from idea to market-ready product in a structured and regulatory-compliant manner.

There are selected four different early-stage medtech startups that will go through this Competence Development Program. The participants will still be part of the Beyond Beta Program, which means they have access to e.g. accelerator camps and mentoring. All participants are allocated a local business hub mentor (based of geograpfy) and a cluster mentor (based of their business area), in which the four medtech start-ups have been assigned to Danish Life Science Cluster.

DESCRIPTION OF THE TASK UNDER MARKET EVALUATION
We seek a comprehensive competence development program for four different early-stage medtech startups. The program should include:

• Mechanical and/or electronic medtech device prototyping:
  Introduction to prototype stages (looks-like, works-like, test models, presentation models), selection of prototype level based on development phase and purpose (user testing, regulatory documentation, investor pitch, etc.), and hands-on work in a prototyping lab (CNC, 3D printing, electronics, testing facilities).
• Regulatory compliance (MDR):
  Overview of EU Medical Device Regulation (MDR), step-by-step guidance on documentation and risk management, practical exercises in translating technical specifications into regulatory documentation, and case studies on early product development.
• Product maturation for production:
  Design for Manufacturing (DFM), cost-of-goods (COGS) analysis, identification and screening of manufacturers across material types, assessment of quality systems and regulatory aspects in production selection, and preparation of supplier specifications.
• Supply chain management and quality agreements:
  Introduction to supplier and quality agreements (QA agreements), risk-based supply chain management, and processes for traceability, batch management, and supplier evaluation.
  The program will be delivered through workshops, project reviews, individual and group sparring, and a “see one – do one” mentorship approach.

TASK OBJECTIVES AND SUCCESS CRITERIA
Objectives:

• The Program must run between November 2025 to October 2026
• Equip startups with a clear understanding of prototype stages and the ability to select the right tools at the right time.
• Ensure participants can meet regulatory minimum requirements during development.
• Provide practical tools for analyzing COGS, quality, and supplier selection.
• Enable startups to draft and implement quality agreements and establish a robust supply chain.

Success Criteria:

• Startups demonstrate improved regulatory compliance and product development skills.
• Participants can independently analyze and document COGS and supplier quality.
• Implementation of quality agreements and supply chain processes in participant projects.
   

BUDGET AND SPECIFICATION OF AN OFFER

The task should be completed as a fixed-price offer covering all the consultant’s expenses related to the task.
The budget for the tender is a maximum of DKK 500.000 excluding VAT.

The consultant must clearly indicate the price with reference to roles, specialties, and experiences in the solution description, as well as the employees (consultants) and the organization they are part of.
Expenses for subcontractors must be included in the fixed-price offer. 

We expect a written offer to include at least:

• Brief presentation of the bidder, including CVR number and contact details, with references and history if relevant
• Bidder’s proposal for solving the task
• Specification of the price for solving the task 
• Discount, if relevant
• Timeframe and end date
• Conditions for the offer, if any

BACKGROUND FOR THE TENDER
Beyond Beta is subject to requirements for sound financial management, including documentation that the agreed price for external purchases reflects the market price. This tender is part of these requirements.
Only the requested task should be included in the offer; services of an executing or implementing nature cannot be approved.
The winning bid will be selected based on the best correlation between price and quality.